Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Backs Puma Breast Cancer Drug; Biogen MS Drug Fampyra Picks up Full EU A

Regulatory Recon: FDA Panel Backs Puma Breast Cancer Drug Biogen MS Drug Fampyra Picks up Full EU Approval (24 May 2017)

Posted 24 May 2017 | By Michael Mezher 

Regulatory Recon: FDA Panel Backs Puma Breast Cancer Drug Biogen MS Drug Fampyra Picks up Full EU Approval (24 May 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • When the Patient Is a Gold Mine: The Trouble With Rare-Disease Drugs (Bloomberg)
  • Trump's 2018 Budget Seeks Last-Minute Renegotiation of FDA User Fee Deals (Focus) (FDA Law Blog)
  • FDA Advisory Committee Backs Puma's Breast Cancer Drug (Live Blogs) (Forbes) (The Street)
  • FDA Safety Initiatives Could Suffer Under Trump's Budget Proposal (Pink Sheet-$)
  • Gottlieb Establishes FDA Committee to Confront Opioid Crisis (Focus)
  • Perrigo, Taro Show Perils of Failure to Branch in Branded Drugs (The Street)
  • Trump's Quiet on Drug Pricing, But His FDA Isn't (Bloomberg)
  • The FDA refuses to lift a clinical hold on Cel-Sci's PhIII drug (Endpoints)
  • A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker (Focus)
  • The Pharma Pipeline Report Card 2017, An Infographic (SCRIP-$)
  • Nearly every $100,000 drug approved in the last three years was for a rare disease (MM&M)
  • Actions Needed to Ensure Improved Response to Zika Virus Disease Outbreaks (GAO 1, 2)
  • FDA Reviewers Express Concerns About Emmaus' SCD Data (BioCentury)
  • Leader of moderate Republican House group resigns over healthcare (Reuters)
  • Trump's Medicaid Funding Change Could Alter Drug Access, Rebates (Pink Sheet-$)
  • Putting A Lid On Waste: Needless Medical Tests Not Only Cost $200B — They Can Do Harm (KHN)
  • Data sharing in clinical trials: An experience with two large cancer screening trials (Plos)

In Focus: International

  • EMA proposal concerns: "Public health trumps commercial confidentiality" (InPharmaTechnologist)
  • Full green light for Biogen's MS drug Fampyra (PharmaTimes) (GEN) (Press)
  • German court favors vaccination of child in parents' dispute (Reuters)
  • EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulation (EMA)
  • UK biotech boasts Europe's best pipeline as Brexit threat looms (Reuters)
  • Cuts to AIDS Treatment Programs Could Cost a Million Lives (NYTimes)
  • WHO Elects First African Director-General (Focus)
  • New WHO head seeks US bipartisan support for global health (Reuters)
  • Ge Li's fast-growing WuXi Biologics sets the stage for a $513M IPO (Endpoints)
  • NICE nod for psoriatic arthritis drugs Cimzia and Cosentyx (PharmaTimes)
  • July Deadline For EMA Relocation Bids; Member States Begin Scrutiny Of Proposed Hosting Criteria (Pink Sheet-$)
  • EMA's PRIME A Year On: Hits And Misses When It Comes To Applications (Pink Sheet-$)
  • Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (Focus)

Pharmaceuticals & Biotechnology

  • AstraZeneca's Bydureon cleared a heart safety test, but didn't cut risks. Can it still vie with Novo? (Fierce) (SCRIP-$)
  • ACRO Opposes "Right to Try" in Policy Statement (Press)
  • A Reality Check on Amazon's Pharmacy Ambitions (Drug Channels)
  • FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures (Focus)
  • Thoughts on An Antibody Failure (In the Pipeline)
  • A New Factor in Protein Folding (In the Pipeline)
  • A Bipartisan Way to Lower Drug Prices (Bloomberg)
  • Unconventional Collaborators, Like FDA, for Early Adoption of New Technology (Xconomy)
  • Scrip Asks… Is The Biosimilar Cost-Saving Theory Sustainable? (SCRIP-$)
  • US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant (InPharmaTechnologist)
  • Sanofi/Regeneron's Kevzara Priced To Break Into A Crowded Market (SCRIP-$)
  • FDA Warning Wire: Pharma Staff Kept Info 'In Their Heads' (Law360-$)
  • No silver bullet, but precision oncology can help doctors hit the target (PharmaLetter-$)
  • Bone Therapeutics Looks To ALLOB Data Progress (SCRIP-$)
  • Cancer resistance firm TP Therapeutics reaps $45M in third round (Fierce)
  • Pfizer bows first Ibrance TV spot as Novartis revs up with rival breast cancer med Kisqali (Fierce)
  • Hard charging Neurocrine hit with a sudden setback as Tourette study flops (Endpoints) (Fierce)
  • Antibiotics found to fail in quarter of pneumonia patients (Pharmafile)
  • Less promo, more info: Annual physician poll finds docs want fewer pharma ads, more education (Fierce)
  • Amgen: Bioprocess intensification and integration key for next-generation manufacturing (BioPharmaReporter)
  • GE looks to single-use modular BioParks to relieve capacity investment risk (BioPharmaReporter)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab (Press)
  • New data at ATS add to the body of evidence for Roche's Esbriet (pirfenidone) in idiopathic pulmonary fibrosis (IPF) (Press)
  • FDA Approves Pembrolizumab for Pancreatic Cancers with Mismatch Repair Deficiency (Press) (Press)
  • NeuroVive To Take Traumatic Brain Injury Drug Into Mid-Stage Studies (SCRIP-$)
  • Liquidia Technologies Announces Positive Phase 1 Data for LIQ865, Sustained-Delivery PRINT Formulation of Bupivacaine for Post-Surgical Pain Relief (Press)
  • Akebia Initiates Phase 2 FO2RWARD Study of Vadadustat in Dialysis Patients with Anemia Related to Chronic Kidney Disease Hyporesponsive to Treatment with Erythropoiesis-Stimulating Agents (Press)

US: Medical Devices

  • HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange (FDA)
  • The Coming Wave of Dual-Chamber Systems for Drug Delivery (MDDI)
  • Apple Watch detects atrial fibrillation using built-in technology (MDDI)
  • This could be the battery-free solution for pacemakers (MassDevice)
  • BioVentrix touts 1st clinical use of Revivent for ischemic cardiomyopathy (MassDevice)
  • GI Dynamics touts weight loss, lowered HbA1c in EndoBarrior meta-analysis (MassDevice)
  • Glaukos touts economic savings in dual iStent study (MassDevice)
  • Philips picks up airway clearance device dev RespirTech (MassDevice)
  • Novartis' Ultibro Breezhaler tops inhaled corticosteroid for COPD in head-to-head study (Drug Delivery)

US: Assorted & Government

  • N.D. Florida Permits (Some) Discovery of Expert Who Changed from Consulting to Testifying Expert (Drug & Device Law)
  • Generic Drug Price-Fixing MDL Fuels Worries For Defendants (Law360-$)
  • Judge Greenlights Merck's $60M Deal In Pay-For-Delay MDL (Law360-$)
  • Latest J&J Pelvic Mesh Injury Case Kicks Off In Philly (Law360-$)
  • Patients Slam Bayer, Janssen's Bid To Cut Xarelto Claims (Law360-$)
  • Abbott's Depakote 'Most Toxic' Drug For Fetuses, Jury Told (Law360-$)

Upcoming Meetings & Events


  • Debiopharm buys ImmunoGen ADC to grow cancer pipeline (Fierce)
  • Pierre Fabre buys up Igenica preclinical I-O meds (Fierce)


  • CFDA Minister Bi Jingquan meets Director of the Office of Strategic Programs of the US FDA CDER and Chair of ICH Management Committee Dr. Theresa Mullin (CFDA)
  • Shanghai Henilus Biotech Has Blockbuster Biologics In Biosimilars Crosshairs (SCRIP-$)
  • China's CANbridge Life Sciences gains $25M series B, plots new cancer trials (Fierce)


  • India's generics project can bring down medicine costs globally: WHO India head (Economic Times)
  • DoP rejects Wockhardt's plea of irrational & unscientific to calculate average PTR on dosage basis in case of liquid formulations (PharmaBiz)
  • NIPER Ahmedabad to be developed as testing centre for medical device industry as per govt mandate (PharmaBiz)
  • Strides Shasun gets USFDA nod for dementia drug (Economic Times)
  • US FDA accepts application for psoriasis drug: Sun Pharma (Economic Times)


  • TGA presentation: Immunotherapy@Brisbane, 11 February 2017 (TGA)

Other International

  • More funds for Colombian crenezumab trial in Alzheimer's (PharmaLetter-$)
  • Yemen cholera caseload leaps, death toll rises: WHO (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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